BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD GLUCOSE SYSTEM

    MDR report key: 5178178 · Received October 26, 2015

    Report

    Report Number
    1052693-2015-02097
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 30, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4) *TYPE OF REPORTABLE EVENT, INADVERTENTLY "DEATH" WAS SELECTED, THE CORRECT OPTION IS "MALFUNCTION". RETURNED METER AND TEST STRIPS EVALUATED WITH NO DEFECT FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD POOR TECHNIQUE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER'S MOTHER STATES HER SON FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-140MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/20/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 67MG/DL (B)(6) 2015 04:36:00 PM FASTING:YES, 176MG/DL (B)(6) 2015 04:54:00 PM FASTING:YES 58MG/DL (B)(6) 2015 04:55:00 PM FASTING:YES, 224MG/DL (B)(6) 2015 04:56:00 PM FASTING:YES, 139MG/DL (B)(6) 2015 05:59:00 PM FASTING:YES, CUSTOMERS CONCERN: 67MG/DL (B)(6) 2015 04:36:00 PM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINS OF LOW RESULTS. CUSTOMER'S MOTHER STATES HER SON FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. THE CUSTOMER'S EXPECTED BLOOD RESULTS ARE 80-140MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 06/20/2018. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. REVIEWED METER MEMORY: 1:67MG/DL (B)(6) 2015 04:36:00 PM FASTING:YES. 2:176MG/DL (B)(6) 2015 04:54:00 PM FASTING:YES. 3:58MG/DL (B)(6) 2015 04:55:00 PM FASTING:YES. 4:224MG/DL (B)(6) 2015 04:56:00 PM FASTING:YES. 5:139MG/DL (B)(6) 2015 05:59:00 PM FASTING:YES. CUSTOMERS CONCERN: 67MG/DL (B)(6) 2015 04:36:00 PM FASTING:YES. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708380 BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PS2376

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR